The Pharmaceutical Care Management Association (PCMA) released a statement in support of the Food and Drug Commissioner’s call to publish a list of off-patent drugs that may be vulnerable to price-fixing. Read More »
BioPharma Services Inc. recently passed three Food and Drug Administration inspections without a single Form 483 being issued. Read More »
Merck has received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for ISENTRESS, a 600 mg. tablet coated in film and paired with other anti-retroviral prescriptions for those who have been diagnosed HIV-1. Read More »
The FDA says it is willing to look into and evaluate a drug that could help treat children who suffer from seizures. Read More »
Puma Biologics reports the U.S. Food and Drug Administration has posted the documents that were used for briefing at the Oncologic Drugs Advisory Committee (ODAC) May 24. Read More »
Abbott recently announced that its molecular test, the Abbott RealTime Zika Test, has been authorized by the U.S. Food and Drug Administration (FDA). Read More »
The U.S. Food and Drug Administration (FDA) has permitted the use of subcutaneous Actemra (tocilizumab) to assist adults who are receiving treatment for giant cell arteritis. Read More »
EMED Technologies Corp.'s SCIg60 Infusion System is the first Immune Globulin Subcutaneous (Human) mechanical pump infusion system to be approved by the U.S. Food and Drug Administration. Read More »
The U.S. Food and Drug Administration has given Bayer a priority review for its New Drug Application for copanlisib, a drug to be used for relapses of refractory follicular lymphoma in individuals who have had a minimum of two therapies. Read More »
Amgen announced May 18 a Biologics License Application which they submitted to the U.S. Food and Drug Administration for a migraine prevention medication. Read More »
The drug Kalydeco was recently approved to treat additional case of gene mutations in cystic fibrosis patients, the U.S. Food and Drug Administration reported on May 17 in a press release. Read More »
The FDA recently approved Abon Pharmaceuticals' Abbreviated New Drug Application for its Clofarabine Injection as a treatment for pediatric patients who suffer from relapsed or refractory acute lymphoblastic leukemia, a deadly cancer disease. Read More »
Zimmer Biomet Holdings' Gel-One Cross-linked Hyaluronate has been approved by the U.S. Food and Drug Administration. Read More »
The U.S. Food and Drug Administration has approved Siliq (brodalumab) as a treatment for adults with moderate-to-severe plaque psoriasis. Read More »
The first new drug approved specifically to treat amyotrophic lateral sclerosis (ALS), commonly referred to a Lou Gehrig’s Disease, in over two decades was approved in less than a year, thanks in large part to the FDA working in conjunction with Mitsubishi Tanabe Pharma Corp. and the ALS Association. Read More »
The Food and Drug Administration has approved Genentech's Lucentis as a treatment for all forms of diabetic retinopathy, the leading cause of blindness among working age adults in the country. Read More »
EMD Serono has received Food and Drug Administration approval of BAVENCIO (avelumab) as a treatment for locally advanced or metastatic urothelial carcinoma. Read More »
Pharmacy benefit managers should be praised for helping to keep down the cost of prescription drugs, rather than attacked by Congress and others, according to one health policy adviser. Read More »
Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), has been accepted by the U.S. Food and Drug Administration. Read More »
AbbVie, a global biopharmaceutical company, recently announced its Viekirax + Exviera eight-week treatment program has been granted a positive opinion by the European Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
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